Arthrosis of First Carpometacarpal Joint, Joint Diseases, Musculoskeletal Diseases or Conditions, Osteoarthritis, Osteoarthritis Thumb
Conditions
Keywords
Touch® prothesis, RSI, Resection-suspension-interposition arthroplasty, Thumb carpometacarpal joint, Dual mobility prosthesis
Brief summary
The study aims to determine whether CMC I arthroplasty using a Touch® implant results in higher patient satisfaction compared to RSI arthroplasty in the medium-term in patients with primary thumb osteoarthritis. Additionally, the study compares the patients' clinical and self-reported outcomes between the Touch® implant and the RSI arthroplasty. Therefore, patients with a Touch® implant in one thumb and an RSI arthroplasty in the other thumb will be recruited.
Detailed description
Patients suffering from osteoarthritis in the first carpometacarpal joint (CMC I OA) are often surgically treated with a resection-suspension-interposition (RSI) arthroplasty. An alternative technique is an arthroplasty with a Touch® implant. There is a growing body of evidence indicating that patients with a Touch® prosthesis recover significantly faster and return to work more quickly than patients after an RSI arthroplasty. However, there have been no studies comparing the two operations in the same patient. By recruiting patients with a Touch® implant in one thumb and an RSI arthroplasty in the other thumb, this study aims to investigate whether CMC I arthroplasty using a Touch® implant leads to higher patient satisfaction compared to RSI arthroplasty in the medium-term. Further patient-reported and clinical outcomes will be assessed to compare the two surgeries.
Interventions
DEVICETouch® Prosthesis
The Touch® prosthesis is a medical device approved in Switzerland, which is an effective surgical treatment for advanced CMC I osteoarthritis.
Sponsors
Schulthess Klinik
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Informed Consent signed by the patient. * Patient is diagnosed with primary OA in both CMC I joints and was operated with a Touch® prosthesis on one thumb and with an RSI arthroplasty on the other thumb.
Exclusion criteria
* Patient with any type of revision surgery at the CMC I joint * Patient underwent hand surgery within the last three months * Legal incompetence
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient satisfaction wiht treatment result using 5-point Likert scale | Follow-up at least 3 months to 12 years after surgery | 5-point Likert scale ranging from 1 (very dissatisfied) to 5 (very satisfied) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Additional aspects of patient satisfaction with treatment | Follow-up at least 3 months to 12 years after surgery | Questionnaire |
| Differences between both thumbs | Follow-up at least 3 months to 12 years after surgery | Questionnaire |
| Brief Michigan Hand Outcomes Questionnaire (MHQ) | Follow-up at least 3 months to 12 years after surgery | The german version of the brief MHQ will be used to assess patient-reported hand function. The score ranges from 0 to 100 with higher scores indicating better hand function. |
| Grip strength assessed with Jamar Dynamometer | Follow-up at least 3 months to 12 years after surgery | Jamar Dynamometer |
| Sociodemographic information | Follow-up at least 3 months to 12 years after surgery | Questionnaire |
| Range of motion of the humb metacarpal (MCP) and interphalangeal (IP) joint assessed with a goniometer | Follow-up at least 3 months to 12 years after surgery | Used to measure flexion and extension of the thumb metacarpal (MCP) and interphalangeal (IP) joint. The evaluation of active thumb opposition is based on the Kapandji index, ranging from 1 (can touch only the lateral side of the index finger) to 10 (can reach the volar crease of the hand). |
| Pain at rest and during activities of daily living (ADL) assessed using Numeric rating scales (NRS) | Follow-up at least 3 months to 12 years after surgery | NRS ranging from 0 (no pain) to 10 (worst pain) |
| Radiographs of both thumbs | Follow-up at least 3 months to 12 years after surgery | To monitor the implant and to assess the scaphometacarpal distance, which can be used to identify migration of the thumb metacarpal bone, a phenomenon often observed after trapeziectomy. |
| Key pinch strength assessed with pinch gauge | Follow-up at least 3 months to 12 years after surgery | Pinch gauge |
Countries
Switzerland
Outcome results
None listed